{% if overall_pass %}
Overall Verdict: PASS — all media satisfy f2 >= 50
{% else %}
Overall Verdict: FAIL — one or more media fall below f2 >= 50
{% endif %}
Multi-Media f2 Summary
| Medium |
f2 |
f1 |
Timepoints |
Criterion |
Status |
{% for medium in media_names %}
{% set r = per_media_results[medium] %}
| {{ medium }} |
{{ "%.2f"|format(r.f2_value) }} |
{{ "%.2f"|format(r.f1_value) }} |
{{ r.n_timepoints }} |
f2 ≥ 50 |
{% if r.f2_value >= 50 %}
PASS
{% else %}
FAIL
{% endif %}
|
{% endfor %}
Interpretation:
Multi-media dissolution comparison across {{ media_names|length }} conditions.
f2 ≥ 50 indicates similarity between {{ reference_label }} and {{ test_label }}
at the given pH/medium condition per FDA guidance for
immediate-release oral solid dosage forms.
Dissolution Profiles by Medium
{% for medium in media_names %}
{% set r = per_media_results[medium] %}
{{ medium }} — Detailed Results
| Parameter |
Value |
Criterion |
Status |
| f1 (Difference Factor) |
{{ "%.2f"|format(r.f1_value) }} |
0 – 15 |
{% if r.f1_value <= 15 %}
PASS
{% else %}
FAIL
{% endif %}
|
| f2 (Similarity Factor) |
{{ "%.2f"|format(r.f2_value) }} |
≥ 50 |
{% if r.f2_value >= 50 %}
PASS
{% else %}
FAIL
{% endif %}
|
| Time (min) |
{{ reference_label }} Mean (%) |
{{ test_label }} Mean (%) |
Difference (%) |
{% for t, ref, tst in zip(r.time_points, r.reference_mean, r.test_mean) %}
| {{ t }} |
{{ "%.2f"|format(ref) }} |
{{ "%.2f"|format(tst) }} |
{{ "%.2f"|format(tst - ref) }} |
{% endfor %}
{% endfor %}
Disclaimer
Regulatory Notice
{{ disclaimer }}
